IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS

Basic Information

• Brand Name: IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS
• Primary DI: 00630414974187
• Version / Model: 10380037
• Catalog Number: LSCP
• Company Name: SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
• Labeler DUNS: 186812384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: 2c69a597-07e0-4084-b0fc-6e9a56c3a0d6

Device Description

IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414974187	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]